Not yet recruitingOBSERVATIONAL

Role of Fibrinolytic Activity in Neoplastic Pathologies Complicated by Coagulopathy

This research aims to understand how a specific blood substance, called plasminogen, is involved in clotting problems that can affect people with certain cancers or severe infections like septic shock. We know that conditions like blood cancers, advanced solid tumours, and septic shock can sometimes lead to serious issues with bleeding or blood clots. By measuring plasminogen levels, we hope to find out if these levels can predict who might be at higher risk of these complications. This information could then help doctors provide better and more tailored care in the future, improving safety and recovery for patients. This study will collect a small extra blood sample during routine care to gather this important data.

At a glance

Status

Not yet recruiting

Sponsor

University Hospital, Strasbourg, France

Enrolment target

150

Start

01 Jan 2026

Estimated completion

01 Feb 2028

Hematologic Neoplasms Solid Tumor Metastatic Cancer Advanced Cancer Disseminated Intravascular Coagulation

What is this study about?

This study is trying to understand more about how our blood clots, especially in people who have certain types of cancer or a severe infection called septic shock. When you have conditions like blood cancer, advanced solid (non-blood) tumours, or septic shock, your body's ability to clot blood can sometimes go wrong. This can lead to either too much bleeding, which is dangerous, or too many blood clots forming, which can also cause serious problems. In this study, we're focusing on a substance in your blood called plasminogen, which plays a key role in breaking down blood clots.

The main goal is to measure how much plasminogen is in the blood of people with these conditions and those experiencing clotting issues, often referred to as 'coagulopathy'. We want to see if the levels of plasminogen can tell us anything about whether someone is more likely to bleed or to form clots. This information is really important because if we can predict these complications early, doctors might be able to step in and manage them more effectively, potentially leading to better outcomes for patients. For example, if low plasminogen is linked to a higher risk of bleeding, doctors might consider different treatments or monitoring strategies.

This is an early stage of research. The information we gather from this study isn't about treating or curing these conditions directly right now. Instead, it's about building a better understanding so that future, larger studies can be designed. Ultimately, the hope is that this research will pave the way for new ways to predict, prevent, or better manage bleeding and clotting problems in people with these serious health issues, improving their safety and well-being.

Key takeaways

This study investigates blood clotting in people with certain cancers and conditions like septic shock.
It aims to understand if a blood substance called plasminogen predicts bleeding or clotting problems.
Participation involves giving a small extra blood sample during routine tests.
There are no new treatments or medications involved.
The findings could help improve future patient care and safety.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To be able to take part in this study, you would need to be over 18 years old and currently in hospital in areas like emergency medicine, intensive care, or cancer care. You would also need to have a specific type of blood clotting problem, which doctors call 'coagulopathy', identified by low levels of tiny cells that stop bleeding (platelets) and a blood test called INR that shows how long it takes your blood to clot.

Depending on your health condition, you might fit into one of three groups. Group 1 includes people with certain blood cancers like acute leukaemia or lymphoma with specific features. Group 2 is for people with advanced solid cancers, such as prostate, pancreatic, or digestive tract cancers, who also have a specific clotting condition called DIC. Group 3 is a 'control' group with septic shock (a severe response to infection), which helps us compare the results.

There are also reasons why you wouldn't be able to join. For example, if you're under legal guardianship, pregnant, weigh less than 50kg, or have certain other blood clotting disorders that developed from birth. People who are currently on blood thinners for treatment, have active bleeding, liver scarring (cirrhosis), or have already been in this study before would also not be eligible. If you're in one of the cancer groups, you couldn't have a severe infection (sepsis) at the time of joining, as this would put you in a different study group.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you over 18 years old?
Are you in hospital in an emergency, intensive care, or cancer unit?
Do you have problems with your blood clotting (low platelets AND high INR)?
Are you pregnant or weigh less than 50kg? (No to be eligible)
Do you have a different type of blood clotting disorder that developed from birth? (No to be eligible)
Are you currently taking blood thinning medication for treatment reasons? (No to be eligible)

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the process will be quite simple. An additional small amount of blood will be taken when you are already having blood drawn for your routine hospital tests and follow-up care. This means you won't need any extra needles or separate appointments just for the study. The researchers will then analyse these blood samples to measure different markers related to blood clotting, including plasminogen levels. There are no additional hospital visits or medications specifically for this study. The study team will just be collecting information from your blood samples and your medical records over a period of 28 days from when you join. Your total involvement will mainly be the collection of that extra blood sample and allowing the research team to review your anonymous medical information (blood test results, complications) for 28 days.

Potential risks and benefits

The potential benefits of taking part in this study are indirect. You might not personally experience a direct health benefit from participating, but your contribution will be very valuable. The information gathered from your blood samples will help doctors learn more about how certain conditions affect blood clotting. This knowledge could lead to better ways to predict and manage serious complications like bleeding or blood clots in the future, ultimately improving care for other patients. The main risk involved is very small, as it only involves having a slightly larger volume of blood taken at the same time as your routine blood tests. This might feel like a minor pinch, but it avoids any extra procedures. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Hôpitaux Universitaires de Strasbourg
Verified postcode
Strasbourg, France

Common questions

What is plasminogen and why are you studying it?

Plasminogen is a substance in your blood that helps break down blood clots. We're studying it to see if its levels can predict bleeding or clotting problems in people with certain diseases.

Will I get any medicine from this study?

No, this study does not involve giving any new medicines. It's an observational study, meaning we are just collecting information from your blood samples.

How much extra blood will be taken?

A small extra amount of blood will be drawn at the same time as your routine blood tests, so you won't need any additional needle sticks.

Will this study change my current medical treatment?

No, taking part in this study will not change your current medical treatment or care in any way. It's purely for research purposes.

What happens to my personal information?

Your personal information will be kept confidential. We will only use anonymous results from your blood samples and medical records for the research.

How to find out more

Raphaël Clere-Jehl

raphael.clere@chru-strasbourg.fr +33 3 88 12 82 23 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.